Ignite Creation Date:
2025-12-25 @ 12:03 AM
Ignite Modification Date:
2026-01-02 @ 4:24 AM
Study NCT ID:
NCT06689358
Status:
COMPLETED
Last Update Posted:
2024-11-14
First Post:
2024-11-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Thoracic Paravertebral Block for Postoperative Pain Management After VATS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002045', 'term': 'Bupivacaine'}], 'ancestors': [{'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Arm 1: General anesthesia with TPVB; Type: Experimental Intervention: 0.4 ml/kg of 0.5% bupivacaine injected into the thoracic paravertebral space.\n\nArm 2: General anesthesia alone (control group). Type: No intervention (control) Intervention: No intervention'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 81}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2024-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-13', 'studyFirstSubmitDate': '2024-11-06', 'studyFirstSubmitQcDate': '2024-11-13', 'lastUpdatePostDateStruct': {'date': '2024-11-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Opioid requirement in the PACU', 'timeFrame': 'Opioid requirement assessed at 5 minutes, 15 minutes, 30 minutes post-PACU admission, and at PACU discharge (up to 4 hours)', 'description': 'Opioid requirement in the PACU, recorded as "yes" or "no."'}], 'secondaryOutcomes': [{'measure': 'Pain intensity measured by Numeric Rating Scale -NRS', 'timeFrame': 'Pain intensity measured using the Numeric Rating Scale (NRS) at 5 minutes, 15 minutes, 30 minutes post-PACU admission, and at PACU discharge (up to 4 hours)', 'description': 'Pain intensity measured by Numeric Rating Scale- NRS at several time points, Range: 0 (no pain) to 10 (worst imaginable pain), Interpretation: Higher scores indicate worse pain intensity'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Opioids, Pain Management,', 'Thoracic Paravertebral Block. VATS', 'Regional Anesthesia'], 'conditions': ['Pain, Postoperative']}, 'descriptionModule': {'briefSummary': 'This randomized controlled trial evaluated the efficacy of a thoracic paravertebral block (TPVB) in reducing opioid requirements and pain intensity in the PACU after video-assisted thoracoscopic surgery (VATS).', 'detailedDescription': 'This randomized controlled trial evaluated the efficacy of a thoracic paravertebral block (TPVB) in reducing opioid requirements and pain intensity in the PACU after video-assisted thoracoscopic surgery (VATS). Adult patients scheduled for elective VATS who meet the eligibility criteria will be randomized to either Arm:\n\nArm 1: General anesthesia with TPVB;\n\nArm 2: General anesthesia alone (control group).\n\nPrimary Outcome: to assess Opioid requirement in the PACU'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients scheduled for elective VATS, ASA physical status II-III, BMI 19-40.\n\nExclusion Criteria:\n\n* Patient refusal, coagulation disorders, contraindications to TPVB, chronic analgesic use, mental illness'}, 'identificationModule': {'nctId': 'NCT06689358', 'briefTitle': 'Thoracic Paravertebral Block for Postoperative Pain Management After VATS', 'organization': {'class': 'OTHER', 'fullName': 'King Hussein Cancer Center'}, 'officialTitle': 'Thoracic Paravertebral Block for Postoperative Pain Management in PACU After VATS Surgeries: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '22 KHCC 158'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'General anesthesia with TPVB', 'description': '0.4 ml/kg of 0.5% bupivacaine injected into the thoracic paravertebral space', 'interventionNames': ['Drug: 0.4 ml/kg of 0.5% bupivacaine']}, {'type': 'NO_INTERVENTION', 'label': 'General anesthesia alone (control group).', 'description': 'General anesthesia SOC alone'}], 'interventions': [{'name': '0.4 ml/kg of 0.5% bupivacaine', 'type': 'DRUG', 'description': '0.4 ml/kg of 0.5% bupivacaine injected into the thoracic paravertebral space', 'armGroupLabels': ['General anesthesia with TPVB']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11941', 'city': 'Amman', 'country': 'Jordan', 'facility': 'King Hussein Cancer Center', 'geoPoint': {'lat': 31.95522, 'lon': 35.94503}}], 'overallOfficials': [{'name': 'Ahed Al-Edwan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'KHCC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'King Hussein Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}